Getting Started
Preparing for IRB Submission
Students, residents, and fellows may serve as Principal Investigator on IRB submissions, but must identify a faculty advisor for their project. The faculty advisor should have experience with human subjects research and be familiar with the UTHSC IRB submission process and policies. They will serve as a mentor throughout the application process and study conduct. You will be prompted to name your faculty advisor in the IRB electronic application.
As Principal Investigator, you are responsible for the overall conduct of the study and the actions of everyone working on it. Please review the UTHSC IRB policy on Responsibilities of Investigators before beginning your project.
Make sure all key study personnel (KSP) associated with the project have a UT NetID (username) and password so that they can be added to and/or access the IRB electronic system, DASH Research IRB.
Non-UTHSC users who do not have a UT NetID will have to be sponsored into the UT system. UT students will also need to request a UT Net ID to access DASH Research IRB. To request a UT Net ID for non-UTHSC individuals, email irb@uthsc.edu; please have ready the following information for UT NetID requests: name, date of birth, social security number, phone number, email address, and institution/department affiliation. Do not send this sensitive information via regular email! Consult Encrypt Your Email for instructions on emailing confidential information.
Note: Non-UTHSC KSP must either:
- provide IRB approval from their institution to participate in the study or an IRB Authorization/Reliance Agreement may need to be executed; OR
- sign an Individual Investigator Agreement if they are with an institution that does not have its own IRB. Consult the Reliance Agreement page and/or call the IRB for guidance: 901.448.4824.
Note:To access DASH Research IRB, researchers will need to install the Duo Mobile App to enable two-factor authentication.
All KSP associated with your project must complete the UTHSC Collaborative Institutional Training Initiative (CITI) education on the protection of human research volunteers before the IRB can approve your project. CITI courses must be passed at 85% or higher. Approved CITI training expires every 3 years.
- Our office will verify your UTHSC CITI training is up to date with each of your IRB submissions.
TO GET CITI CERTIFICATION:
- Go to Collaborative Institutional Training Initiative (CITI)
- Complete either
- The UTHSC Basic Human Subject Protections and Good Clinical Practices combination course OR
- The Human Subjects Training Basic Biomedical (Biomed) course AND
- The GCP for Clinical Trials with Investigational Drugs & Medical Devices (U.S. FDA focus) course. These courses have more modules, but for 3-year recertification, you can complete a shortened refresher course.
IF YOU OBTAINED CITI CERTIFICATION AT ANOTHER INSTITUTION/ORGANIZATION WITHIN THE LAST 3 YEARS:
- affiliate your certification with UTHSC by following the online instructions on the CITI website.
IF YOU OBTAINED HUMAN SUBJECTS PROTECTION AND GOOD CLINICAL PRACTICE TRAINING AT ANOTHER INSTITUTION (investigators new to UTHSC or collaborating from another institution):
- Completed certificate and course modules will be reviewed for reciprocity. If the coursework is not comparable, additional modules may be assigned, or researchers must complete one of the two course options noted above.
For information about UTHSC IRB policy and DASH Research IRB (electronic application system) training opportunities, visit our Training webpage. IRB policy training is strongly encouraged for all KSP for compliance with federal regulations, state law, and local IRB policy.
Training for IRB Policy and submissions: You may request a one-on-one training from the IRB. IRB policy and training is highly encouraged!
Go to DASH Research IRB to log into the electronic application system. Click the IRB tab. Next click "Create a New Study." NOTE:
- The Study SmartForm Single or Multi-Site electronic form will collect basic study information (study title, funding source/s, local key study personnel, study scope, and local research locations.)
- You will be prompted to upload local site documents, such as protocol, consent form/s, recruitment materials, data collection instruments, etc.
- If you are unsure about which IRB protocol (Exempt/Not Human Subject Research (NHSR), Expedited, or Full Board review) to upload, please contact the IRB office at 901.448.4824 or refer to the Levels of IRB Review.
- The IRB provides Submission Checklists to assist with IRB submission
If you have questions regarding the IRB electronic application, contact the IRB office at 901.448.4824. In addition, consult the DASH Research IRB Sharepoint site for videos and step-by-step instructions
Before you submit an application, you must obtain the signature of the investigators using the Acknowledgement of Investigator's Responsibilities & Signatures. (See table below).
| Type of Submission | Required Signature(s) |
| Study SmartForm Single or Multi-Site |
|
| Modification and Continuing Review SmartForm |
|
If you will be conducting your project at one of our partner sites (Campbell Clinic, Le Bonheur Children’s Hospital, Methodist Healthcare- Memphis Hospitals, Regional One Health, or Semmes Murphey), or if your project is associated with any of our partners, review the information on the IRB Partners webpage for administrative requirements set by these organizations.
If you will be conducting your project at a non-UTHSC partner site, a letter from administration at that institution permitting you to conduct research there will be required. Call the IRB with any questions: 901.448.4824.